跳至主要内容
临床试验/NCT07805395
NCT07805395招募中2 期

Building Capacity for Youth Mental Wellness: Feasibility and Acceptability for a Mental Health Family Navigator Model for Foster Parents (FN+ Phase 2)

Northwestern University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年9月5日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Post Session Questionnaire

研究概览

简要总结

The investigators have designed a 5-week Family Navigator Plus (FN+) educational program to support foster parents in better understanding their youth's mental health needs and in finding mental health services. The purpose of this interventional study is to assess the the program's acceptability (e.g., satisfaction, barriers to participation, and burden), utility (e.g., how useful foster parents found the program to be), and feasibility (e.g., number referred who meet eligibility, time to complete assessments, self-reported feasibility), compared to Attention Control (AC). The investigators hypothesize that our program will be acceptable, useful, and feasible for foster parents of youth with mental health needs.

详细描述

We will conduct a pilot RCT (n = 60) as a test of the FN+ Program feasibility and preliminary effectiveness to improve individual-level variables, relative to Attention Control (AC). The primary outcome will be increased foster parent activation (P-PAM-MH). Secondary outcomes include reduced barriers to treatment and perceived change in parent capacity to manage youth MH care. Randomization: We will use simple randomization to assign foster parents to condition. Foster parents (n=60) will be randomized to the either the FN+ or AC. We will pilot all randomization procedures including those designed to prevent allocation bias. Randomization will be conducted by a research analyst who is blind to hypotheses and is not involved in any other aspect of the study. The research analyst will only share the names and condition assignment with the FNs who do not know study aims or hypotheses and will keep research staff blinded to condition. The ACHW will conduct all outcome data and remain blind to condition. The ACHW will remain masked to treatment assignment until the trial is complete. Success in masking will be monitored using the Evaluator Masking Assessment upon the completion of each data collection time point for each parent. Inclusion and Exclusion criteria are the same as Aim 2 with the addition that any foster parent that participated in Aim 1 or 2 will be excluded from the RCT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Foster parent, kinship caregiver, or guardian, of a youth between the ages of 6 to 17 with mental health needs
  • Parent adopted child from foster care
  • Living in Illinois, United States
  • English speaking
  • Has access to internet and videoconferencing

排除标准

  • Participated in the FN+ Focus Groups, Open Trial or PROACTIVE Parent Pilot Study

研究组 & 干预措施

Civic Engagement Plus

Active Comparator

Participants will attend 5 one-on-one sessions over the course of 5 weeks; they will meet with a family navigator over video conferencing software (e.g., Zoom). The purpose of each sessions are as follows: 1) defines civic engagement within a developmental framework, and guides foster parents in discussing their child's developmental level, strengths, and opportunities for civic participation. 2) identifies developmentally appropriate civic activities and strategies to initiate and support youth involvement. 3) emphasizes goal setting, age-appropriate engagement strategies, collaboration with caseworkers, and structured problem-solving to address barriers to participation. 4) setting developmentally appropriate goals, 5) finding digital tools. Participants will complete measures of child symptoms, parent activation, barriers to treatment, and/or satisfaction with the program before the intervention, immediately after the intervention, and 3 months after completing the intervention.

干预措施: Civic Engagement Plus (Behavioral)

Family Navigator Plus

Experimental

Participants will attend 5 one-on-one sessions over the course of 5 weeks; they will meet with a family navigator over video conferencing software (e.g., Zoom). The purpose of each sessions are as follows: 1) Provide an overview of the program and help parents understand their perceptions of child behaviors, 2) Train parents to find, access, and overcome barriers to mental health services, 3) Build parent capacity in understanding how mental health treatment works and how to communicate with providers, 4) Help parents understand the common function of child behaviors, and 5) Train parents to find, evaluate, and use online mental health tools. Participants will complete measures of child symptoms, parent activation, barriers to treatment, and/or satisfaction with the program before the intervention, immediately after the intervention, and 3 months after completing the intervention.

干预措施: Family Navigation (Behavioral)

结局指标

主要结局

Post Session Questionnaire

时间窗: Time Frame: After Completing Each Session (Weeks 1 - 5)

Description: The Post Session Questionnaire is a measure we created to assess utility and relevance of session content and materials, and to assess if participants intended to use skills/information learned during that session. Response options range from 1 - 4. Higher scores mean participants found the content more useful.

Client Satisfaction Questionnaire (CSQ)

时间窗: Time Frame: Post-Intervention (Week 5) and 3 Month Follow Up (Week 18)

Description: The Client Satisfaction Questionnaire (CSQ-8) is an eight-item measure that assesses client satisfaction with services including its quality, utility, and relevance. Response options range from 1 - 4. Higher scores mean participants found to be of high quality, met their needs, etc.

次要结局

  • Parent-Patient Activation Measure - Mental Health(Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18))
  • Barriers to Treatment Participation Scale(Baseline (week 1), Post-Intervention (week 5), 3 month Follow - Up (week 18))
  • PROMIS Parent Proxy Depressive Symptoms Short Form(Time Frame: Baseline (Week 1), Post-intervention (week 5), 3 month follow up (week 18))
  • PROMIS Parent Proxy Anxiety Short Form(Time Frame: Baseline (Week 1), Post-intervention (week 5), 3 month follow up (week 18))
  • Pediatric Symptom Checklist - 17(Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Risser

Assistant Professor

Northwestern University

研究点 (1)

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